CosmoFer® (LMW Iron Dextran) 50mg/ml, 5 x 2 ml Ampoules
CosmoFer® is a solution of iron and is given as an infusion into a vein (intravenous infusion). The sugar to which iron is attached is called dextran. CosmoFer® is used to treat iron deficiency (lack of iron in the body) when you cannot tolerate iron tablets, or if high doses of iron are needed to correct the iron deficiency. If there is a lack of iron in the body, the bone marrow cannot produce a sufficient number of red blood cells. A low number of red blood cells is called anaemia.
CosmoFer® is used for low levels of iron (sometimes called ‘iron deficiency’) if:
- You cannot take iron by mouth, for example you cannot tolerate it
- You have taken iron by mouth and it has not worked
- Your doctor decides you need iron very quickly to build up your iron stores
Other Brands: InFeD®, Imferon®, Dexferrum®, Feosol®, Proferdex®, Iron Dextran
1 ml of solution contains the active substance – Iron (III) Hydroxide-Dextran Complex – 312.5 mg (equivalent to 50.0 mg of ferric iron)
Excipient: water for injection
Indications for use
Only for adults and children over 14 years old
– the clinical need for rapid transport of iron to its depot
– ineffectiveness or intolerance to iron preparations for oral administration.
The diagnosis of iron deficiency should be based on appropriate laboratory tests (eg, serum ferritin, serum iron, transferrin, hypochromic red blood cell saturation).
In the second and third trimesters of pregnancy, treatment with Cosmofer should be prescribed only when absolutely necessary and only after a thorough assessment of the benefits to the mother and the potential risk to the fetus.
The use of CosmoFer is possible only in a hospital under conditions of the availability of resuscitation measures, anti-shock therapy, medical personnel who have experience in assessing anaphylactic reactions and carrying out resuscitation measures.
Test dose: (all routes of administration)
Before the introduction of the first dose, it is necessary to carry out a test dose: enter the CosmoFer test dose corresponding to 25 mg of iron or 0.5 ml of solution, respectively.
Observation time: 60 minutes. If during this time no side reactions are observed, then the remaining dose of the drug is administered.
Anaphylactoid reactions to CosmoFer, as a rule, appear within a few minutes, it is necessary to ensure careful monitoring of the patient. If there are signs of an allergic reaction or intolerance, the administration of CosmoFer should be stopped immediately.
Application: CosmoFer solution for injection can be applied by intravenous drip or by slow intravenous injection, among which the preferred method is intravenous drip, as this can help reduce the risk of hypotension. CosmoFer is also intended for intramuscular administration without dilution of the solution.
Dosage: the recommended dosage regimen is a single (daily) dose of 100-200 mg of iron, which corresponds to 2-4 ml of solution, 2-3 times a week. The duration of treatment depends on the target hemoglobin content of 150 g / l or 9.3 mmol / l and iron depot 500 mg. However, if clinical circumstances require rapid delivery of iron to the depot in the body, then CosmoFer can be administered intravenously as an infusion in a total dose corresponding to iron of 20 mg / kg of body weight.
Should not be administered concurrently with oral iron preparations (absorption of iron from the gastrointestinal tract decreases).
For adults and the elderly: the total total dose of CosmoFer is determined by the initial hemoglobin level and body weight. The dosage and scheme of application of the CosmoFer drug should be set individually for each patient based on the calculation of the total iron deficiency.
Children under 14 years of age: CosmoFer should not be administered to children under 14 years of age due to the lack of safety and efficacy data.
Intravenous drip: CosmoFer should be administered with 0.9% sodium chloride solution (saline) or 5% glucose solution. CosmoFer in a dosage of 100-200 mg of iron (2-4 ml) must be diluted in 100 ml of saline or glucose. The first 25 mg of iron is administered over 15 minutes. If during this time no side reactions are observed, then the remaining dose of the solution is administered at an infusion rate of no more than 100 ml in 30 minutes.
Intravenous slow administration: CosmoFer can be administered at a dosage of 100-200 mg of iron (2-4 ml) by intravenous slow administration (0.2 ml / min) diluted in 10-20 ml of 0.9% sodium chloride solution or in 5% solution glucose. For slow intravenous administration, the first 25 mg of iron should be slowly injected over 1–2 minutes. If no adverse reactions are observed within 15 minutes after the administration of the test dose, then the remaining dose of the drug can be administered.
Note: Intravenous drip is preferred over slow intravenous injection.
Introduction of the total course dose: when prescribing the total course dose of CosmoFer determined by calculations and according to the table below. The calculated amount of the drug is diluted under aseptic conditions in 500 ml of sterile isotonic sodium chloride solution or 5% glucose solution. The total amount of CosmoFer is administered intravenously for about 4-6 hours. The first 25 mg of iron is administered over 15 minutes. When the drug is administered, the patient must be under the direct supervision of a physician. If during this time there are no side reactions, then the remaining dose is administered.
The infusion rate can be increased gradually to 45-60 drops per minute.
The use of the total course dose is possible if the doctor has experience in using the drug in a single dose. Intravenous administration of the total dose of CosmoFer should be carried out only in a hospital setting.
Patients should be under close medical supervision during the infusion and for at least 1 hour after the end of the infusion.
Introduction to the dialyzer: CosmoFer can be applied during a hemodialysis procedure directly into the venous part of the dialyzer, following the same procedures as prescribed for intravenous administration.
Intramuscular injection: the drug should be injected only into the muscle mass of the outer upper quadrant of the buttock, it should not be injected into the arm or other area of the body.
The drug in a dosage of 100 mg of iron (2.0 ml) is prescribed for patients leading a moderately active lifestyle, daily alternating the injection site; for patients leading an inactive lifestyle, or bedridden patients, the frequency of injections is reduced to 1 or 2 per week.
The drug should be injected deep into the muscle, in the upper outer quadrant of the buttock. For adults, a 20-21G needle at least 50mm in length should be used; for obese patients, needles with a length of 80–100 mm are used, and for children over the age of 14, needles are used smaller and shorter (23 G × 32 mm). The patient should lie on his side with the injection side up or stand with the weight of the body on the leg free from the injection. To avoid penetration of the drug into the subcutaneous tissue, the Z-shaped technique of skin displacement before injection is recommended. CosmoFer is injected slowly and carefully. It is important to wait a few seconds before pulling out the needle to allow the muscle mass to “adjust” to the volume of the injected drug. It is not recommended to rub the injection site.
Test dose – 25 mg of iron (0.5 ml of solution). If no adverse reactions occur within 60 minutes, the remaining dose is administered.
Calculation of the course dose
For patients with iron deficiency anemia
The required dose should correspond to the total iron deficiency – hemoglobin in g / l or mmol / l:
Total dose (Fe in mg) – hemoglobin in g / l:
body weight (in kg) x (required Hb g / l – actual Hb g / l) x 0.24 + iron in mg for replenishing iron stores
The factor 0.24 is derived from the following assumptions:
a) blood volume 70 ml / kg of body weight ≈7% of body weight
b) iron content in hemoglobin 0.34%
Factor 0.24 = 0.0034 * 0.07 * 1000 (transition from g to mg).
Total dose (Fe in mg) – hemoglobin in mmol / l:
body weight in kg x (target Hb in mmol / l – actual hemoglobin in mmol / l) x 3.84 + iron in mg to replenish iron stores.
The coefficient 3.84 is derived from the following assumptions:
a) blood volume 70 ml / kg body weight ≈ 7% of body weight
b) hemoglobin 0.34% iron
c) the coefficient of conversion from hemoglobin from g / l to mmol / l – 0.06205
Factor 3.84 = 0.0034 x 0.07 x 1000 / 0.06205
Calculations are given for a target hemoglobin level of 150 g / l, iron stores of 500 mg with a body weight of more than 35 kg.
The table and corresponding formula are applicable for dose determination only in patients with iron deficiency anemia.
The table and formula should not be used to determine the dose in those patients requiring iron replacement due to blood loss.
Total iron requirement reflects the amount of iron needed to restore hemoglobin levels to normal or near normal levels, plus the additional amount needed to carry out sufficient iron replenishment in most people with moderate or excessive hemoglobin decline. It must be remembered that iron deficiency anemia will not manifest until all iron stores are depleted. Therapy, therefore, should be aimed not only at replenishing hemoglobin with iron, but also at replenishing the iron store in general.
If the total required dose exceeds the maximum permissible daily dose, the administration should be carried out in several doses.
The therapeutic effect can be observed a few days after the application of CosmoFer and is manifested in the form of an increase in the number of reticulocytes. Serum ferritin levels are a good indicator of iron replenishment. In dialysis patients receiving CosmoFer, this correlation may not appear.
The table below shows the number of milliliters of CosmoFer injection solution needed to treat varying degrees of iron deficiency anemia and is not used to determine the dose in case of iron replacement in bleeding.
The total dose of CosmoFer, in milliliters:
|Body weight (kg)||Hemoglobin content|
|60 g/l||75 g/l||90 g/l||105 g/l||120 g/l||135 g/l|
For patients with blood loss
Iron therapy in patients with blood loss should aim to replenish the amount of iron equivalent to the amount of iron in the lost blood. The above table and formulas are not suitable for quick iron replenishment. Quantifying human blood loss and hematocrit during bleeding is a convenient way to calculate the required iron dose.
The required dose of CosmoFer to compensate for iron deficiency is calculated according to the following formulas:
If the amount of blood lost is unknown:
The introduction of 200 mg of iron (4 ml of Cosmofer) leads to an increase in hemoglobin equivalent to 1 unit of blood (= 400 ml with a content of 150 g of hemoglobin per liter or 9.3 mmol of hemoglobin / l corresponding to an iron content of 0.34% of 0.4 x 150, i.e. 204 mg of iron).
Iron to be replaced (mg) = number of blood units lost x 200
Cosmofer (in ml) = number of blood units lost x 4
If your hemoglobin level is low:
The previous formula should be used, according to which the iron store does not need to be restored.
Amount of iron (mg) to be replaced = body weight (kg) × 0.24 × (target hemoglobin g / l – actual hemoglobin g / l).
Iron (mg) = body weight in kg x 3.84 x (target Hb in mmol / L – actual hemoglobin in mmol / L).
For example: body weight = 60 kg, hemoglobin deficiency = 10 g / l
The amount of iron to be replaced = 60 x 0.24 x 10 = 143 mg (about 3 ml of CosmoFer).
Possible side effects
– nausea, vomiting, abdominal pain
– anaphylactic reactions, including dyspnea, urticaria, rash, itching, nausea, tremors
– blurred vision, numbness
– redness, itching, rash
– arrhythmia, tachycardia
– pain and discoloration at the injection site
– loss of consciousness, anxiety, seizures, dizziness, tremors
– chest pain
– change in mental state, angioedema, increased sweating
– fetal bradycardia, increased heart rate
– transient hearing loss
– very severe anaphylactic reactions (sudden breathing difficulties and / or cardiovascular collapse)
– headache, paresthesia
– hypotension, hypertension
– swollen lymph nodes
– first trimester of pregnancy
– children under 14 years old
– anemia not caused by iron deficiency (eg, hemolytic anemia)
– an oversaturation of the body with iron or a violation of its excretion (i.e. hemochromatosis, hemosiderosis)
– patients suffering from asthma, eczema or other types of atopic allergies
– hypersensitivity to the drug, including iron mono- or disaccharide complexes and dextran
– decompensated liver cirrhosis and hepatitis
– acute or chronic infection, as parenteral iron administration can exacerbate bacterial or viral infections
– rheumatoid arthritis with symptoms or signs of active inflammation
– acute renal failure.
Pharmaceutical. The use of CosmoFer is contraindicated if the patient is taking other iron supplements or oral iron supplements. CosmoFer injection solution contains iron in a stable aqueous hydroxide-dextran complex, which is similar to the physiological form of iron, ferritin. The drug is characterized by a stable collodial complex, in the center of which is iron, surrounded by closely related dextran chains. The sterile solution has a neutral pH, approximately 5.2 to 6.5. Sodium hydroxide or hydrochloric acid is used to stabilize the pH. The solution does not contain any preservatives. Dextran iron complexes for parenteral administration are distinguished by their stability and speed of release in serum.
Pharmacodynamic. CosmoFer injections should not be taken in parallel with oral medications, as the absorption of oral iron will be reduced. Oral iron therapy should be started no earlier than 5 days after the last injection of CosmoFer. You must promptly notify your doctor or pharmacist about any other medicines you are using or have recently used, even if you purchased them yourself.
Pharmacokinetic. The use of large doses of iron (III) -hydroxide dextran complex (5 ml or more) can give a brown color to serum, in blood samples taken four hours after taking the drug. The medication can cause erroneously high bilirubin and low serum calcium.
Other types of drug interactions: there is no data on the interaction of CosmoFer with food and tobacco.
Special warning and precautions for use
CosmoFer should be diluted only with 0.9% sodium chloride solution or 5% glucose solution. Dilution with other solutions or therapeutic agents is not allowed.
The use of the drug Cosmofer can, like other iron-carbohydrate complexes, increase the risk of immediate severe or life-threatening anaphylactic reactions. Patients should be under medical supervision during and immediately after drug administration. There is an increased risk for patients with known allergies. Acute anaphylactic reactions are extremely rare. They appear within the first minutes of use and are usually characterized by a sudden onset of breathing difficulties and / or cardiovascular collapse.
When the first signs of anaphylactic reactions appear, the use of CosmoFer should be discontinued immediately.
The use of CosmoFer in patients with autoimmune diseases or inflammatory conditions (systemic lupus erythematosus, rheumatoid arthritis) can cause type III allergic reactions.
Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia and sometimes fever, which can last from several hours to 4 days after drug administration. Symptoms usually appear within 2–4 days.
The diagnosis of iron deficiency should be based on appropriate laboratory tests (serum ferritin, serum iron, transferrin iron saturation). Cosmofer can be used only when funds and equipment are available for emergency care in acute anaphylactic reactions, including 1: 1000 adrenaline solution, glucocorticoids, H1-histamine receptor blockers. For the introduction of a test dose, see “Dosage and Administration”.
Intramuscular and subcutaneous administration of iron-carbohydrate complexes in large doses under experimental conditions in animals, the development of sarcoma was observed in rats, mice, rabbits, hamsters, but not in guinea pigs. The accumulated information and their independent assessment show that the risk of developing sarcoma in humans is minimal.
With rapid intravenous administration, hypotension is observed.
Warning: while taking the drug, you must refrain from drinking alcohol.
Pregnancy and lactation
There are no adequate data on the use of Cosmofer in pregnant women. Animal studies have shown reproductive toxicity. Cosmofer should not be administered during the first trimester of pregnancy. In the second and third trimesters of pregnancy, treatment with Cosmofer should be prescribed only when absolutely necessary and only after a thorough assessment of the benefits to the mother and the potential risk to the fetus.
It is not recommended to use Cosmofer during lactation.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms:
There is no data on the effect on the ability to drive a vehicle or potentially dangerous machinery.
Overdosage of CosmoFer Infusion
Symptoms: Overdose can cause acute iron accumulation, which may present with symptoms of hemosiderosis.
In chronic poisoning as a result of the administration of high doses of the drug, excess iron accumulates in the liver and causes an inflammatory process that can lead to fibrosis
Treatment: symptomatic therapy is carried out, iron-binding drugs are prescribed.
How to store CosmoFer
- Store in a dry, dark place at a temperature of 18 ° to 25 ° C.
- Do not freeze. Inspect ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution.
- Keep out of the reach and sight of children.
Shelf Life: 30 months
CosmoFer should not be used after the expiry date